Hospitals and medical device manufacturers have more cybersecurity guidance and requirements than ever, but third-party attacks, AI-assisted vulnerability discovery, and aging equipment continue to complicate efforts to reduce risk.
The association announces the location and advisory council for its 2027 medical device standards conference, scheduled for April 13–16 in National Harbor, Maryland.
The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
Hospitals and medical device manufacturers have more cybersecurity guidance and requirements than ever, but third-party attacks, AI-assisted vulnerability discovery, and aging equipment continue to complicate efforts to reduce risk.
For HTM teams, parts sourcing decisions depend on far more than price or availability.
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Service manuals aren’t optional or proprietary “extras” in a hospital. They’re required for safe maintenance and compliance, and they should be non-negotiable at purchase.
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Revised guidance aligns with quality management system regulation changes and provides recommendations for cyber device submissions under section 524B of the FD&C Act.
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The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.
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The hospital association urges the FDA to adopt risk-based post-market oversight for AI-enabled medical devices while aligning new requirements with existing regulatory frameworks.
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New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.
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The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.
